The igniting spark for your MedTech Start-up

Consulting & Coaching 
for MedTech Start-ups

tecurat GmbH – Well advised right from the start

Setting direction

tecurat GmbH gives you a first enlightening insight into the seemingly endless expanses of laws & standards around the development & approval of medical devices.

Product tailored

Right from the start, we familiarize you with the requirements necessary to consider for the development of your medical device. – So that you don't waste unnecessary resources.

Sharing responsibility

In addition to knowledge transfer, we actively support you in assuming your responsibility as a manufacturer and complementing your team in important roles until your crew is complete.

Do you take the EU-MDR as the only valid set of rules for obtaining a CE mark?

Your development is already in full motion but the requirements of your stakeholders have not yet been defined?

Your team has not yet reached the scope & expertise to cover all required roles company internal?

Do these thoughts sound familiar? Then contact us to get answers to your open questions and Make an appointment with us!

From the idea to the production & marketing of your medical device

Comprehensive expert

coaching & training for start-ups

We will teach you how to avoid the key pitfalls to save valuable time & resources. So that your safe medical device passes the approval in the most efficient way & with flying colors.

Innovation as a beacon of hope
The enthusiasm to develop a medical device that is seen as a beacon of hope for a certain patient population is usually slowed down when confronted with the standards of the medical device industry for the first time.

Legal hurdle
The impression quickly arises that laws & standards are sheer harassment of manufacturers and lack a real benefit.

tecurat GmbH has set itself the goal of taking on the horrors of start-ups in the medical device industry and making the meaningfulness of the regulations plausible by an easily understandable and pragmatic demonstration of the respective requirements.

Safety & Performance – the main characters
However, if you look at a product from the patient’s point of view – whose role you could all too quickly assume yourself – it becomes apparent that process monitoring is indispensable with respect to safety & performance. Furthermore, the aspects of quality & documentation take on a different status in the internal chain of argumentation before the MDR instigating implant scandal.

Medical Device Life Cycle
Our training courses on normative requirements are designed to familiarize you with your obligations as a manufacturer in an easily un-derstandable way. In doing so, we consider the entire life cycle of your product with the associated requirements for product & company.

Excerpt of our training offer

Excerpt of our training offer Regulations:

Employee qualifications
Moreover, we train your employees according to their tasks & responsibilities as:

If you build a strong foundation right at the beginning of your business start-up, there are no limitations to expansion.

Our services:

Find out more about our range of services that can benefit your start into the MedTech universe under the following points:

Creating a QM manual

We create your QM manual as a basic framework for your QM system.

Preparing for audits

Together we prepare the technical documentation for your audit.

Taking on roles

We support you with our offer of interim management.

tecurat GmbH - Your ideal partner for your medical device
if you want to build your business on a solid and compliant foundation

We are happy to be there for you

How can we help you?
Contact us.

Meet up with us:
In the office or online – or send us an email whenever you want.

We look forward to meeting you!


+49 331 600 87 640